EV01:: A phase I trial in healthy HIV negative volunteers to evaluate a clade CHIV vaccine, NYVAC-C undertaken by the EuroVacc Consortium

被引：55

作者：

Bart, Pierre-Alexandre ^{[2
]}

Goodall, Ruth ^{[1
]}

Barber, Tristan ^{[3
]}

Harari, Alexandre ^{[2
]}

Guimaraes-Walker, Ana ^{[3
]}

Khonkarly, Mona ^{[2
]}

Sheppard, Neil C. ^{[4
]}

Bangala, Yolanda ^{[2
]}

Frachette, Marie-Joelle ^{[5
]}

Wagner, Ralf ^{[6
]}

Liljestrom, Peter ^{[7
]}

Kraehenbuhl, Jean-Pierre ^{[8
]}

Girard, Marc ^{[9
]}

Goudsmit, Jaap ^{[10
]}

Esteban, Mariano ^{[11
]}

Heeney, Jonathan ^{[12
,13
]}

Sattentau, Quentin ^{[4
]}

McCormack, Sheena ^{[1
]}

Babiker, Abdel ^{[1
]}

Pantaleo, Giuseppe ^{[2
]}

Weber, Jonathan ^{[3
]}

机构：

[1] MRC, Clin Trials Unit, London NW1 2DA, England

[2] CHU Vaudois, CH-1011 Lausanne, Switzerland

[3] St Marys Hosp, London, England

[4] Univ Oxford, Oxford, England

[5] Sanofi Pasteur, Lyon, France

[6] Univ Regensburg, Regensburg, Germany

[7] Karolinska Inst, Stockholm, Sweden

[8] Eurovacc Fdn, Lausanne, Switzerland

[9] CNRS, Lyon, France

[10] Univ Amsterdam, Acad Med Ctr, NL-1105 AZ Amsterdam, Netherlands

[11] Ctr Nacl Biotecnol, Madrid, Spain

[12] Biomed Primate Res Ctr, Rijswijk, Netherlands

[13] Univ Cambridge, Cambridge, England

来源：

VACCINE | 2008年 / 26卷 / 25期

基金：

英国医学研究理事会;

关键词：

HIV preventative vaccine; NYVAC-C; phase I;

D O I：

10.1016/j.vaccine.2008.03.083

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

NYVAC-C (vP2010), a recombinant vector expressing HIV subtype C gag, pot, env and nef antigens, was tested in a phase I study in healthy, HIV negative volunteers in London and Lausanne. Twenty-four participants were randomised to receive NYVAC-C (20) or matching placebo (4) at weeks 0 and 4, and assessed for safety and immunogenicity over 48 weeks. There were no serious adverse events, and no clinical or laboratory abnormalities or other events that led to withdrawal, interruption or dose reduction of the NYVAC-C/placebo. Half of the 10 assessed responded in the ELISpot assay under stringent criteria, which informed the sample size for a DNA-NYVAC-C comparison to NYVAC-C alone. (C) 2008 Elsevier Ltd. All rights reserved.

引用

页码：3153 / 3161

页数：9

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